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NCT02715648 Clinical Trial

Using Phenazopyridine for In-office Cystoscopy

Cystoscopy Clinical Trial

Official title:
Using Phenazopyridine for In-office Cystoscopy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02715648
Other study ID # 003-2016
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2016
Est. completion date June 1, 2021

Study information
Verified date December 2020
Source Boston Urogynecology Associates
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators propose to conduct a randomized controlled trial to evaluate whether administration of phenazopyridine prior to the procedure decreases office cystoscopy time. Women undergoing in-office cystoscopy at Boston Urogynecology will be recruited.

Description:

All potentially eligible participants will have had a complete history, physical examination, urinalysis and urine culture for clinical purposes. After eligibility is confirmed and written, informed consent is obtained, participants will be randomized to one of the two study arms. Participants randomized to phenazopyridine arm will receive 200 mg by mouth approximately 60 minutes prior to the scheduled cystoscopy. During the cystoscopy, at various time points, the time will be recorded.The color of the efflux will also be documented.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 94
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Female patients undergoing in-office diagnostic cystoscopy at Boston Urogynecology Associates Exclusion Criteria: - Women who have taken vitamin B the day of the cystoscopy - Cystoscopy with concurrent treatments such as botulinum toxin or periurethral bulking injections - Allergy to phenazopyridine

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Phenazopyridine

Locations
Country Name City State
United States Boston Urogynecology Associates, 725 Concord Ave. Suite 1200 Cambridge Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Boston Urogynecology Associates

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total cystoscopy time The total time of cystoscopy will be measured at time of cystoscopy
Secondary Time to visualization of ureteral jets The time to visualization of the first ureteral jet will be recorded at time of cystoscopy
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